Self-Expanding Heart Valve Anchor for Precise Endovascular Placement
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Solution Overview
Problem
Current methods for endovascular heart valve replacement face challenges such as irreversible deployment, inaccurate placement, high risk of blocking coronary ostia, and lack of radial strength, leading to potential migration and dysfunction of the replacement valve.
Innovation Solution
A method involving a self-expanding anchor with a replacement valve that can be dynamically repositioned and locked in place, allowing for visualization and assessment before full deployment, using a deployment tool with control wires and tubes to enhance radial strength and prevent migration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a self-expanding stent is used for valve replacement, then the valve can be deployed without a delivery balloon, but the placement accuracy deteriorates because the stent jumps upon release and cannot be precisely positioned
Solution Approach 1:
The stent is pre-constrained within a delivery catheter before deployment. The delivery catheter acts as a positioning guide that holds the stent in the correct location until final deployment, preventing the stent from jumping or migrating during the procedure. This preliminary constraint enables both easy deployment and precise placement.
Solution Approach 2:
The delivery catheter serves as an intermediary tool between the stent and the target position. It provides a controlled environment for stent deployment, allowing the stent to be released at the precise location intended by the operator while maintaining placement accuracy throughout the procedure.
2Adaptability or versatility
If the stent is released early to allow repositioning, then placement flexibility improves, but the reliability deteriorates because the stent may migrate or block coronary ostia
Solution Approach 1:
The delivery system provides dynamic control over stent deployment timing. The stent remains constrained during delivery and can be released at any point during the procedure, allowing operators to adjust positioning if needed. Once released, the stent maintains stable placement, providing both flexibility and reliability.
Solution Approach 2:
Fluoroscopic imaging provides real-time feedback during the deployment process, allowing operators to monitor stent position and make adjustments by controlling the release timing. This feedback mechanism enables safe repositioning while maintaining overall placement stability.
3Strength
If a balloon-expandable stent is used, then the radial strength is sufficient to prevent migration, but the device complexity increases due to the need for delivery balloon and associated infrastructure
Solution Approach 1:
The delivery balloon is extracted from the final device configuration. The stent is designed to be self-expanding and self-anchoring, eliminating the need for a separate balloon inflation system. This reduces device complexity while maintaining sufficient radial strength through the stent's own structural design.
Solution Approach 2:
The stent is designed to be self-expanding and self-anchoring without requiring external balloon assistance. The stent's own structure provides the radial strength needed to prevent migration, making the system self-sufficient and reducing the complexity of delivery infrastructure.
4Productivity
If the valve is deployed without fluoroscopic guidance, then the procedure speed increases, but the measurement precision of valve position deteriorates
Solution Approach 1:
Radiopaque markers or contrast agents are incorporated into the stent or delivery system to provide visible fluoroscopic guidance. This allows real-time visualization of valve position during deployment, enabling precise positioning without significantly slowing down the procedure.
Solution Approach 2:
Visual feedback through fluoroscopy replaces reliance on mechanical positioning alone. The imaging system provides real-time positional information, allowing operators to adjust the valve position with precision while maintaining procedural efficiency.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables precise placement and functional assessment of the replacement valve, reducing the risk of complications like coronary ostia blockage and valve migration, while maintaining radial strength for effective blood flow regulation.
Implementation Method 1
A method involving a self-expanding anchor with a replacement valve that can be dynamically repositioned and locked in place
Data Source
AI summary
Methods and devices for assessing the operation of a replacement heart valve. The method includes endovascularly delivering a replacement heart valve to a vicinity of a heart valve in an unexpanded configuration, and assessing the operation of the replacement heart valve in the vicinity of the heart valve before fully expanding the replacement heart valve. Methods and devices for assessing the location of a replacement heart valve. The method includes endovascularly delivering a replacement heart valve to a vicinity of the heart valve in an unexpanded configuration, expanding the replacement heart valve to a partially deployed configuration, and assessing the location of the replacement heart valve in the vicinity of the heart valve before fully expanding the replacement heart valve.